Efficacy of Seventh Generation Bonding Agents as Short-Term Desensitizers Among Patients With Hypersensitivity

Dow University of Health Sciences

Status and phase: Completed; Phase 3

Conditions: Dentin Hypersensitivity

Treatments: Drug: Xeno V+; Drug: Single Bond Universal; Drug: Bifluorid 12

Study type: Interventional

Funder types: Other

Identifiers

NCT04225247

2358847

Details and patient eligibility

About

The world lacks a gold standard treatment for treating dentin hypersensitivity. Fluoride varnish is most commonly used as a treatment but it causes temporary discoloration of tooth structure and may cause irritation or burning of gums when it comes in contact with gums. Seventh generation bonding agents are less technique sensitive and are easy to use. The present study aims to find out the better seventh generation bonding agent as a treatment option for sensitivity.

A total of 105 patients with dentin hypersensitivity are randomized into three groups. Scaling and root debridement are performed for all the groups. This study compares two seventh generation bonding agents and taking fluoride varnish as control group.

Full description

Dentin hypersensitivity is a painful condition resulting from external stimulation of exposed vital dentin. Dentin gets exposed to the oral environment by multiple factors like gingival recession, erosion, attrition, abrasion, fractures, caries, and many more. The intra-tubular fluid movement of exposed tubules is believed to be the mechanism of hypersensitivity. Dentin bonding agents acts by occluding patent tubules, thus reducing hypersensitivity. Seventh generation combines etchant, primer and bonding agent into one solution and makes it easy to use.

After diagnosis of dentin hypersensitivity, the patients signed a consent form stating their voluntary participation in the research. The discomfort internal scale score and Schiff cold air sensitivity scale scores are recorded at baseline, immediately after the intervention, after 01 week and after 01 month. Discomfort internal scale score are recorded for every participant using dental explorer in the mesial and distal direction on the exposed surface of the affected teeth for tactile stimulation. For schiff cold air sensitivity scale scores an air syringe system was used to check the evaporative response on the affected teeth of the participants and the scores are recorded.

All the patients received scaling and root debridement as a standard protocol treatment. Dentin bonding agents and fluoride varnish are applied to the participants. All the participants are instructed to fast for two hours after the treatment. All the records are made on subjective response of patients.

Enrollment: 105 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or females of 18 to 45 years of age
• Hypersensitive teeth to air and tactile stimultaion
• Gingival recession of Miller Class I and II
• Score 1 of Silness and Loe Plaque index
• Participants who have no sysytemic illness
• Patients who agree to give consent were included in the study.

Exclusion criteria

• Carious teeth
• Fractured restoration or cracked teeth
• Teeth undergoing orthodontic or periodontal treatment at sensitive site
• Patients who had dental bleaching in last 03 months
• Patients taking pain killers
• Smokers
• Pregnant and nursing females were excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups, including a placebo group

Group-I Single Bond Universal

Active Comparator group

Description:

it is a seventh generation bonding agent used as desensitizer, manufactured by 3M ESPE. applied on the affected surface of the group-I participants.

Treatment:

Drug: Single Bond Universal

Group-II Xeno V+

Active Comparator group

Description:

it is a seventh generation bonding agent used as desensitizer, manufactured by Dentsply. applied on the affected surface of the group-II participants.

Treatment:

Drug: Xeno V+

Group-III Bifluorid 12

Placebo Comparator group

Description:

it is a fluoride varnish used as desensitizer, manufactured by VOCO. applied on the affected surface of the group-III participants.

Treatment:

Drug: Bifluorid 12